EPA in a Bind Over Hazardous Experiments on Humans

After experiments on humans were conducted that exposed them to airborne particulates considered to be lethal, a sound-science advocate has accused physician researchers working for the Environmental Protection Agency of misconduct and violations of the Hippocratic Oath.

“During these experiments, the study subjects were intentionally exposed to airborne fine particulate matter (“PM2.5”) at levels ranging from 41.54 microgramsper cubic meter to 750.83micrograms per cubic meter for periods of up totwo hours,” Milloy wrote to Dr. Ralph C. Loomis, president of the NC Medical Board. “…the EPAhas determined thatPM2.5 is ultrahazardous —i.e., that exposure to even low levels of PM2.5 arepotentially lethal withinhours of exposure and thatno exposure to PM2.5 is safe.

“The EPA alsobelieves thatPM2.5is carcinogenic to humans.”

Milloy cited EPA’s Web site on particulate matter and its 2009 “Summary of PM2.5 Risk Estimates,” which stated, “an examination of cause-specific risk estimates found that PM2.5 risk estimates for cardiovascular deaths are similar to those for all-cause deaths….” Also, in July 2011 EPA stated in the Federal Register announcement of its Cross-State Air Pollution Rule that “a recent EPA analysis estimated that 2005 levels of PM2.5 and ozone were responsible for between 130,000 and 320,000 PM2.5-related and 4,700 ozone-related premature deaths….”

Driving the point home, in September last year EPA Administrator Lisa Jackson (in photo) told the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee, “Particulate matter causes death. It doesn’t make you sick. It’s directly causal to dying sooner than you should.”

As for PM2.5 as a carcinogen, EPA stated in its 2009 assessment that “the evidence is suggestive of a causal relationship between PM2.5 exposures and cancer, with the strongest evidence from the epidemiologic studies of lung cancer mortality.”

With this background knowledge, EPA still subjected human test victims – even those with other risk factors – to intentional exposure of PM2.5. Based upon information he obtained via the federal Freedom of Information Act, Milloy learned that experiments were conducted on 41 subjects. Of those, one experienced atrial fibrillation – a 58-year-old obese woman with a history of health problems and family history of heart disease – and another developed an elevated heart rate. Both returned to normal breathing and heartbeat function within two hours, based upon EPA’s report.

In his letter to the NC Medical Board, Milloy alleged the three doctors violated EPA standards of conduct in human research and the Hippocratic Oath. Among the requirements established by EPA, researchers must minimize risk to subjects and risks must be reasonable compared to anticipated benefits. Test subjects must be fully informed of the risks involved, and studies with “risk of substantial injury to a human subject” are not to be approved except in extremely rare cases that are approved by higher agency authorities.

Likewise Milloy pointed to the Hippocratic Oath, in which doctors must pledge to “exercise my art solely for the benefit of my patients” and “the relief of suffering, the prevention of disease and the promotion of health….” He also doubted whether the human subjects were adequately informed of the risks they would undergo – he has requested via another FOIA copies of those disclosures, but has not received any.

“Not only did Drs. Ghio, Chung and Cascio intentionally expose the 41 human study subjects to ‘killer’ PM2.5,” Milloy wrote to Dr. Loomis, “but the study subjects were exposed to levels of PM2.5 that were…as high as 75 times greater than the national average, 50 times greater than the annual regulatory standard, and 21 times greater than the 24-hour regulatory standard for PM2.5.”

Milloy said there is no evidence that the doctors submitted justification to their authorities “for intentionally exposing humans to PM2.5.” He also told the medical board there was no reason for the experiments as the test subjects would realize no health benefits, nor would the overall population, as EPA determined back in 1997 that human exposure to PM2.5 is “ultrahazardous.”

Besides calling attention to the potential misconduct of the doctors, Milloy revealed the EPA doctors published the case study of only the woman who suffered the cardiac incident in the journal Environmental Health Perspectives. Meanwhile the results of the 40 other test subjects, who experienced “no clinical effects requiring follow-up,” were omitted from the EPA doctors’ report. Instead focusing on the obese, unhealthy subject, their article concluded that “exposure to air pollution including particulate matter may cause supraventricular arrhythmias” – so much for complete, unbiased science coming from EPA.

The upshot – as Milloy explained in an email – is that either EPA truly believes PM2.5 causes cancer and/or instant death and thus their doctors are guilty of misconduct, or they have been lying for years and this research was not harmful after all.

Either EPA’s credibility, or their legal liability, is at stake – as are all the regulations they’ve implemented based upon that premise.

“If PM2.5 does not kill then its utility Mercury Air Toxics Standard and Clean State Air Pollution Rule benefits claims are entirely bogus,” Milloy told me in an email. “Must be one or the other; can't be neither.”

Paul Chesser is an associate fellow for the National Legal and Policy Center.